Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN

K-Number: K834117 · 1984-03-22

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-03-22
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-03-22 under 510(k) number K834117. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN?

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN is a medical device that received FDA 510(k) clearance on 1984-03-22. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K834117.

When did HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN receive FDA 510(k) clearance?

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN received FDA 510(k) clearance on 1984-03-22, under 510(k) number K834117.

Who is the listed applicant for HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN?

The FDA 510(k) record lists Bartels Immunodiagnostic Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN?

The FDA product code for HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN is KIR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLSK861172ROTAVIRUS LATEX AGGLUTINATION ASSAYK860279CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KITK855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTK842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OFK852185RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT

View all 35 devices →

Related Devices (Code: KIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.K973209FRESH CELLS VERODiagnostic Hybrids, Inc.K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.K973214FRESH CELLS HFFDiagnostic Hybrids, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑